Research Operations
The State of Clinical Trial Activation at Sites
While the study activation process is necessary for all sites to conduct, efficiently coordinating all necessary aspects can be challenging.
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
Summary of James Riddle's Presentation at SQA, which outlines considerations for sponsors when ensuring 21 CFR Part 11 compliance at sites.
How to Be Research Ready: Today and Beyond
If presented with a new study, are you prepared to take it on? Efficient study activation can set the pace for a successful clinical trial.
World’s Largest CRO Leverages Partnership With Integrated Central IBC to Initiate Sites in COVID-19 Vaccine Research at Warp Speed
Advarra’s IRB and IBC reviews and Gene Therapy Ready site network helped reduce study startup timelines and delivered trial results to the sponsor quicker than expected.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
Read how an eRegulatory system can increase productivity, improve compliance, and ensure a return on your technology investment.
What is Coverage Analysis in Clinical Research?
This infographic outlines the importance of coverage analysis, consequences to non-compliance, and solutions to avoid non-compliance.
BBK Worldwide Features Advarra Executive Michele Russell-Einhorn in Diversity and Inclusion Video
This video discusses methods IRBs can implement to increase diversity and inclusion among trial participants.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
Q&A from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.
Phase I Oncology Clinical Trials
This blog discusses what makes Phase I oncology trials complex and what IRBs need to know as they review a Phase I trial.
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
Engaging with an expert research compliance partner throughout the clinical development process allows researchers to focus on what matters
3 Strategies to Successfully Engage Participants in Your Trial
A positive participant experience underpins the success of any clinical trial. Leverage these key strategies to ensure success.
Study Activation Survey Results: Budget Negotiation
In late 2020, Advarra conducted a study activation survey. This blog outlines the insights generated surrounding budget negotiation.
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